Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_d332acdf-4874-407b-9950-528f14c6bea2"> </a><p><b>Generated Narrative: Composition</b><a name="d332acdf-4874-407b-9950-528f14c6bea2"> </a><a name="hcd332acdf-4874-407b-9950-528f14c6bea2"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Composition "d332acdf-4874-407b-9950-528f14c6bea2" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ectd-composition-sp4151.html">eCTD Specification Composition</a></p></div><p><b>identifier</b>: ExampleSpecification</p><p><b>status</b>: final</p><p><b>type</b>: Quality Specification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-comp-section-types.html">Code System PQCMC Comp Section Types</a>#SP4151)</span></p><p><b>date</b>: 2023-12-15 22:33:13+0000</p><p><b>author</b>: See on this page: urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a</p><p><b>title</b>: Quality Specification for an example Drug Product</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_aa514363-d43f-4052-b44e-b67aa4d6dee7"> </a><p><b>Generated Narrative: PlanDefinition</b><a name="aa514363-d43f-4052-b44e-b67aa4d6dee7"> </a><a name="hcaa514363-d43f-4052-b44e-b67aa4d6dee7"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource PlanDefinition "aa514363-d43f-4052-b44e-b67aa4d6dee7" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-quality-specification.html">Quality Specification</a></p></div><p><b>Specification Type</b>: Drug Product <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134021)</span></p><p><b>identifier</b>: ExampleSpecification</p><p><b>version</b>: 1.0</p><p><b>title</b>: Quality Specification for OXAZEPAM</p><p><b>type</b>: Workflow Definition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-plan-definition-type.html">PlanDefinitionType</a>#workflow-definition; <a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134011 "Not Approved")</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9</p><p><b>date</b>: 2022-12-08</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>32649771-1290-4386-9cf7-7a72274f22b4</blockquote><p><b>description</b>: Average of 10 between 2-3 pH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>2-3 pH</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>59a4ca76-858e-4d58-8e5f-88e75f51ec33</blockquote><p><b>description</b>: Maxima only at the same wavelengths compared to reference standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Conforms <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>c40aa176-e6aa-4fe4-869d-6550ee992903</blockquote><p><b>description</b>: <= 0.5 % <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>0.5 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>b122987d-586c-481b-951c-6202e660158d</blockquote><p><b>description</b>: Color of solution is clear <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Conforms <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>929747ad-e83a-46f0-bbbc-133ee951e819</blockquote><p><b>description</b>: <= 0.05 % <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>0.05 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>8d7c85c2-7a4b-432e-ac94-226f296e4fca</blockquote><p><b>description</b>: No Particulate Matter detected <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>pass <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>de4f962a-d486-486d-8d84-f2d1635646b4</blockquote><p><b>description</b>: <= 0.014 % <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>0.014 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>b46dce64-a009-46cd-ab95-21d1d5b4df77</blockquote><p><b>description</b>: <= 0.04 % <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>0.04 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>5566f501-37e1-49fb-8783-b20c074ec0c3</blockquote><p><b>description</b>: <= 0.001 % <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>0.001 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>db19e3ab-e28b-4477-8bd7-2409093ed5a3</blockquote><p><b>description</b>: Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>pass <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>82370588-7aae-4556-9262-a7f50dbd01aa</blockquote><p><b>description</b>: Ethanol < 0.2% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Ethanol <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>0.2 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2</blockquote><p><b>description</b>: Ethyl Ether < 0.1% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Ethyl Ether <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>0.1 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>28ad4d5b-d975-4f6e-9792-b3d9cc7ce279</blockquote><p><b>description</b>: 1—propanol < 0.15% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>1—propanol <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>0.15 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>33fa051c-6b3c-4e4d-bd4e-09d39fc253b3</blockquote><p><b>description</b>: Total < 0.5% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Total Residual Solvents <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>0.5 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>9100e938-42ff-4004-8473-ed5090d66f3a</blockquote><p><b>description</b>: 99.5 - 100.5 % <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>99.5-100.5 percent</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>af260128-f105-4692-ba40-49f21f12ad46</blockquote><p><b>description</b>: n=6 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>6</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>31d9dcac-bf72-420b-a415-c924155a83f4</blockquote><p><b>description</b>: Each unit is NLT Q + 5% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>85 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>47c0d685-0b23-4637-9af8-a554e4fad7ec</blockquote><p><b>description</b>: n=6 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>6</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>14d3dee8-e024-4367-b0a2-a2a809303ee0</blockquote><p><b>description</b>: Average of 12 units (S1 + S2) is equal to or greater than Q and no unit is less than Q – 15% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span></p><blockquote><p><b>target</b></p><p><b>measure</b>: Average of 12 units <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>detail</b>: 80 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></p></blockquote><blockquote><p><b>target</b></p><p><b>measure</b>: unit <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>detail</b>: 65 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></p></blockquote></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>15309a78-92a9-4cf9-aee1-452d6d2f7a91</blockquote><p><b>description</b>: Average of 24 units (S1 + S2 + S3) is equal to or greater than Q, not more than 2 units are less than Q – 15%, no unit is less than Q – 25% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span></p><blockquote><p><b>target</b></p><p><b>measure</b>: Average of 24 units <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>detail</b>: 80 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></p></blockquote><blockquote><p><b>target</b></p><p><b>measure</b>: units less than Q – 15% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>detail</b>: 2 amb a 1 units<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C92953 = '[Amb'a'1'U]')</span></p></blockquote><blockquote><p><b>target</b></p><p><b>measure</b>: units less than Q – 25% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>detail</b>: 0 amb a 1 units<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C92953 = '[Amb'a'1'U]')</span></p></blockquote></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>666ace1e-bd29-4263-9ae2-2391106326bb</blockquote><p><b>description</b>: n=12 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>12</td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>2047a6b6-e3fc-4071-8989-526297579091</blockquote><p><b>Test Order | Stage Sequence Order</b>: 1.1</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Spectrophotometry Identification</p><p><b>description</b>: Alternate</p><p><b>code</b>: Spectrophotometry <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC7)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <197></td></tr></table><p><b>goalId</b>: 32649771-1290-4386-9cf7-7a72274f22b4</p><h3>RelatedActions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>TargetId</b></td><td><b>Relationship</b></td></tr><tr><td style="display: none">*</td><td>84d64dd8-b799-418a-a713-a854c4d3c2b9</td><td>concurrent</td></tr></table><p><b>selectionBehavior</b>: exactly-one</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>84d64dd8-b799-418a-a713-a854c4d3c2b9</blockquote><p><b>Test Order | Stage Sequence Order</b>: 1.2</p><p><b>linkId</b>: 2047a6b6-e3fc-4071-8989-526297579091</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Identity - Ferric Chloride</p><p><b>description</b>: Alternate</p><p><b>code</b>: HPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC7)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-01</td></tr></table><p><b>goalId</b>: 59a4ca76-858e-4d58-8e5f-88e75f51ec33</p><h3>RelatedActions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>TargetId</b></td><td><b>Relationship</b></td></tr><tr><td style="display: none">*</td><td>2047a6b6-e3fc-4071-8989-526297579091</td><td>concurrent</td></tr></table><p><b>selectionBehavior</b>: exactly-one</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>838e66ce-f4b0-47a5-8ea0-aa7882a84303</blockquote><p><b>Test Order | Stage Sequence Order</b>: 2</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Loss on Drying</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Loss on Drying <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC12)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <731></td></tr></table><p><b>goalId</b>: c40aa176-e6aa-4fe4-869d-6550ee992903</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>3510686b-fb93-4980-a41c-0a3754be7f37</blockquote><p><b>Test Order | Stage Sequence Order</b>: 3</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Readily Carbonizable Sub</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Organoleptic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC6)</span>, Color of solution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC22)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <271></td></tr></table><p><b>goalId</b>: b122987d-586c-481b-951c-6202e660158d</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>b2e18cc4-f494-4ef0-be34-810d8d4b439b</blockquote><p><b>Test Order | Stage Sequence Order</b>: 4</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Residue on ignition (Ash)</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Residue on Ignition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC38)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <281></td></tr></table><p><b>goalId</b>: 929747ad-e83a-46f0-bbbc-133ee951e819</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>d315a1c3-dd93-498d-8ae3-dc0d4b3bec75</blockquote><p><b>Test Order | Stage Sequence Order</b>: 5</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Substances insoluble in sodium carbonate TS</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Foreign and Particulate Matter <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC11)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-02</td></tr></table><p><b>goalId</b>: 8d7c85c2-7a4b-432e-ac94-226f296e4fca</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>6ec15bbc-a78a-4351-9ad8-fcf97e839ab9</blockquote><p><b>Test Order | Stage Sequence Order</b>: 6</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Impurities - Chloride (Cl)</p><p><b>code</b>: FTIR <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, Specified identified impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC92)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <221></td></tr></table><p><b>goalId</b>: de4f962a-d486-486d-8d84-f2d1635646b4</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>fa31b425-896c-4b25-b693-ccdd14e0c8ee</blockquote><p><b>Test Order | Stage Sequence Order</b>: 7</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Impurities - Sulfate (SO4)</p><p><b>code</b>: FTIR <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, Specified identified impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC92)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <221></td></tr></table><p><b>goalId</b>: b46dce64-a009-46cd-ab95-21d1d5b4df77</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>cef5aa1a-8770-4f78-9bc3-da9f18b77e5c</blockquote><p><b>Test Order | Stage Sequence Order</b>: 8</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Elemental Impurities - Limits</p><p><b>code</b>: UV <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, elemental impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC98)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <231></td></tr></table><p><b>goalId</b>: 5566f501-37e1-49fb-8783-b20c074ec0c3</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>d5871ee2-8b06-414c-91b4-4b30f5881c8a</blockquote><p><b>Test Order | Stage Sequence Order</b>: 9</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Limit of Free Salicylic Acid</p><p><b>code</b>: Titration <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, Impurities/Degradation Products/Related Substances <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC100)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-03</td></tr></table><p><b>goalId</b>: db19e3ab-e28b-4477-8bd7-2409093ed5a3</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>e192fc72-c4b1-419f-8098-6f65037a3962</blockquote><p><b>Test Order | Stage Sequence Order</b>: 10</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Organic Volatile Impurities</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, residual solvent <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC101)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <467></td></tr></table><p><b>goalId</b>: 82370588-7aae-4556-9262-a7f50dbd01aa, cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2, 28ad4d5b-d975-4f6e-9792-b3d9cc7ce279, 33fa051c-6b3c-4e4d-bd4e-09d39fc253b3</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>b7e88ea0-3c61-49db-86ec-8d01f8b7667b</blockquote><p><b>Test Order | Stage Sequence Order</b>: 11</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Assay Dry Basis</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC1)</span>, active ingredient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC2)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-04</td></tr></table><p><b>goalId</b>: 9100e938-42ff-4004-8473-ed5090d66f3a</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>6d1ba5a8-6590-496a-ad6b-ca68cfda2878</blockquote><p><b>Test Order | Stage Sequence Order</b>: 12</p><p><b>title</b>: Dissolution - 30 minute</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Dissolution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC9)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-05</td></tr></table><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>LinkId</b></td><td><b>Prefix</b></td><td><b>GoalId</b></td></tr><tr><td style="display: none">*</td><td/><td>6d1ba5a8-6590-496a-ad6b-ca68cfda2878</td><td>Stage 1</td><td>af260128-f105-4692-ba40-49f21f12ad46, 31d9dcac-bf72-420b-a415-c924155a83f4</td></tr><tr><td style="display: none">*</td><td/><td>6d1ba5a8-6590-496a-ad6b-ca68cfda2878</td><td>Stage 2</td><td>47c0d685-0b23-4637-9af8-a554e4fad7ec, 14d3dee8-e024-4367-b0a2-a2a809303ee0</td></tr><tr><td style="display: none">*</td><td/><td>6d1ba5a8-6590-496a-ad6b-ca68cfda2878</td><td>Stage 3</td><td>15309a78-92a9-4cf9-aee1-452d6d2f7a91, 666ace1e-bd29-4263-9ae2-2391106326bb</td></tr></table></blockquote></div>
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<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
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</addresses>
<target>
<detailRange>
<low>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61583"/>
<display value="NLT (not less than)"/>
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<value value="99.5"/>
<unit value="percent"/>
<system
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<code value="C48570"/>
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<high>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
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<value value="100.5"/>
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<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
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<goal id="af260128-f105-4692-ba40-49f21f12ad46">
<description>
<text value="n=6"/>
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<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
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<target>
<detailInteger value="6"/>
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<goal id="31d9dcac-bf72-420b-a415-c924155a83f4">
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<text value="Each unit is NLT Q + 5%"/>
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<coding>
<system
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<code value="C134029"/>
<display value="Release"/>
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url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
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<code value="C61583"/>
<display value="NLT (not less than)"/>
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<value value="85"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
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<goal id="47c0d685-0b23-4637-9af8-a554e4fad7ec">
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<text value="n=6"/>
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<coding>
<system
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<code value="C134029"/>
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<target>
<detailInteger value="6"/>
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<goal id="14d3dee8-e024-4367-b0a2-a2a809303ee0">
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<text
value="Average of 12 units (S1 + S2) is equal to or greater than Q and no unit is less than Q – 15%"/>
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<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
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<text value="Average of 12 units"/>
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<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61583"/>
<display value="NLT (not less than)"/>
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<value value="80"/>
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<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
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<target>
<measure>
<text value="unit"/>
</measure>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61585"/>
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<value value="65"/>
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value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
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<goal id="15309a78-92a9-4cf9-aee1-452d6d2f7a91">
<description>
<text
value="Average of 24 units (S1 + S2 + S3) is equal to or greater than Q, not more than 2 units are less than Q – 15%, no unit is less than Q – 25%"/>
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<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
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<text value="Average of 24 units"/>
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<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61583"/>
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<value value="80"/>
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<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
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<target>
<measure>
<text value="units less than Q – 15%"/>
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<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61583"/>
<display value="NLT (not less than)"/>
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<value value="2"/>
<unit value="amb a 1 units"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C92953"/>
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<target>
<measure>
<text value="units less than Q – 25%"/>
</measure>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61585"/>
<display value="LT (less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="0"/>
<unit value="amb a 1 units"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C92953"/>
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</target>
</goal>
<goal id="666ace1e-bd29-4263-9ae2-2391106326bb">
<description>
<text value="n=12"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
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<target>
<detailInteger value="12"/>
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<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1.1"/>
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<prefix value="Single Stage"/>
<title value="Spectrophotometry Identification"/>
<description value="Alternate"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Spectrophotometry"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC7"/>
<display value="Identification"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <197>"/>
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<goalId value="32649771-1290-4386-9cf7-7a72274f22b4"/>
<relatedAction>
<targetId value="84d64dd8-b799-418a-a713-a854c4d3c2b9"/>
<relationship value="concurrent"/>
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<selectionBehavior value="exactly-one"/>
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<action id="84d64dd8-b799-418a-a713-a854c4d3c2b9">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1.2"/>
</extension>
<linkId value="2047a6b6-e3fc-4071-8989-526297579091"/>
<prefix value="Single Stage"/>
<title value="Identity - Ferric Chloride"/>
<description value="Alternate"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="HPLC"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC7"/>
<display value="Identification"/>
</coding>
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<documentation>
<type value="documentation"/>
<label value="EX-TEST-01"/>
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<goalId value="59a4ca76-858e-4d58-8e5f-88e75f51ec33"/>
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<targetId value="2047a6b6-e3fc-4071-8989-526297579091"/>
<relationship value="concurrent"/>
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<action id="838e66ce-f4b0-47a5-8ea0-aa7882a84303">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2"/>
</extension>
<prefix value="Single Stage"/>
<title value="Loss on Drying"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC12"/>
<display value="Loss on Drying"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <731>"/>
</documentation>
<goalId value="c40aa176-e6aa-4fe4-869d-6550ee992903"/>
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<action id="3510686b-fb93-4980-a41c-0a3754be7f37">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3"/>
</extension>
<prefix value="Single Stage"/>
<title value="Readily Carbonizable Sub"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
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<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC6"/>
<display value="Organoleptic"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC22"/>
<display value="Color of solution"/>
</coding>
</reason>
<documentation>
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<label value="USP <271>"/>
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<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="4"/>
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<prefix value="Single Stage"/>
<title value="Residue on ignition (Ash)"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
<display value="Compendial"/>
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<text value="Visual"/>
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<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC38"/>
<display value="Residue on Ignition"/>
</coding>
</reason>
<documentation>
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<label value="USP <281>"/>
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<action id="d315a1c3-dd93-498d-8ae3-dc0d4b3bec75">
<extension
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<valueDecimal value="5"/>
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<prefix value="Single Stage"/>
<title value="Substances insoluble in sodium carbonate TS"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
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<text value="Visual"/>
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<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
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<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC11"/>
<display value="Foreign and Particulate Matter"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-02"/>
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<goalId value="8d7c85c2-7a4b-432e-ac94-226f296e4fca"/>
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<action id="6ec15bbc-a78a-4351-9ad8-fcf97e839ab9">
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<valueDecimal value="6"/>
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<prefix value="Single Stage"/>
<title value="Impurities - Chloride (Cl)"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="FTIR"/>
</code>
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<extension
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<valueInteger value="1"/>
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<coding>
<system
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<code value="TC53"/>
<display value="Impurity"/>
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</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
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<coding>
<system
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<code value="SUBC92"/>
<display value="Specified identified impurity"/>
</coding>
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<documentation>
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<valueDecimal value="7"/>
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<prefix value="Single Stage"/>
<title value="Impurities - Sulfate (SO4)"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96102"/>
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<text value="FTIR"/>
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<extension
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<valueInteger value="1"/>
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<coding>
<system
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<code value="TC53"/>
<display value="Impurity"/>
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<reason>
<extension
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<valueInteger value="2"/>
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<coding>
<system
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<code value="SUBC92"/>
<display value="Specified identified impurity"/>
</coding>
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<documentation>
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<valueDecimal value="8"/>
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<prefix value="Single Stage"/>
<title value="Elemental Impurities - Limits"/>
<code>
<coding>
<system
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<code value="C96102"/>
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<text value="UV"/>
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<extension
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<valueInteger value="1"/>
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<coding>
<system
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<code value="TC53"/>
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<reason>
<extension
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<coding>
<system
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<code value="SUBC98"/>
<display value="elemental impurity"/>
</coding>
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<documentation>
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<valueDecimal value="9"/>
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<prefix value="Single Stage"/>
<title value="Limit of Free Salicylic Acid"/>
<code>
<coding>
<system
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<code value="C96103"/>
<display value="Proprietary"/>
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<text value="Titration"/>
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<extension
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<valueInteger value="1"/>
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<coding>
<system
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<code value="TC53"/>
<display value="Impurity"/>
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<reason>
<extension
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<coding>
<system
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<code value="SUBC100"/>
<display
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</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-03"/>
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<action id="e192fc72-c4b1-419f-8098-6f65037a3962">
<extension
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<valueDecimal value="10"/>
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<prefix value="Single Stage"/>
<title value="Organic Volatile Impurities"/>
<code>
<coding>
<system
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<code value="C96102"/>
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<text value="Visual"/>
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<extension
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<coding>
<system
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<code value="TC53"/>
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<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC101"/>
<display value="residual solvent"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <467>"/>
</documentation>
<goalId value="82370588-7aae-4556-9262-a7f50dbd01aa"/>
<goalId value="cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2"/>
<goalId value="28ad4d5b-d975-4f6e-9792-b3d9cc7ce279"/>
<goalId value="33fa051c-6b3c-4e4d-bd4e-09d39fc253b3"/>
</action>
<action id="b7e88ea0-3c61-49db-86ec-8d01f8b7667b">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="11"/>
</extension>
<prefix value="Single Stage"/>
<title value="Assay Dry Basis"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC1"/>
<display value="Assay"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC2"/>
<display value="active ingredient"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-04"/>
</documentation>
<goalId value="9100e938-42ff-4004-8473-ed5090d66f3a"/>
</action>
<action id="6d1ba5a8-6590-496a-ad6b-ca68cfda2878">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="12"/>
</extension>
<title value="Dissolution - 30 minute"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC9"/>
<display value="Dissolution"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-05"/>
</documentation>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1"/>
</extension>
<linkId value="6d1ba5a8-6590-496a-ad6b-ca68cfda2878"/>
<prefix value="Stage 1"/>
<goalId value="af260128-f105-4692-ba40-49f21f12ad46"/>
<goalId value="31d9dcac-bf72-420b-a415-c924155a83f4"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2"/>
</extension>
<linkId value="6d1ba5a8-6590-496a-ad6b-ca68cfda2878"/>
<prefix value="Stage 2"/>
<goalId value="47c0d685-0b23-4637-9af8-a554e4fad7ec"/>
<goalId value="14d3dee8-e024-4367-b0a2-a2a809303ee0"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3"/>
</extension>
<linkId value="6d1ba5a8-6590-496a-ad6b-ca68cfda2878"/>
<prefix value="Stage 3"/>
<goalId value="15309a78-92a9-4cf9-aee1-452d6d2f7a91"/>
<goalId value="666ace1e-bd29-4263-9ae2-2391106326bb"/>
</action>
</action>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9"/>
<resource>
<MedicinalProductDefinition>
<id value="89676a69-1fe7-422c-ab00-92abe4ef6ea9"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-product"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_89676a69-1fe7-422c-ab00-92abe4ef6ea9"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="89676a69-1fe7-422c-ab00-92abe4ef6ea9"> </a><a name="hc89676a69-1fe7-422c-ab00-92abe4ef6ea9"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource MedicinalProductDefinition "89676a69-1fe7-422c-ab00-92abe4ef6ea9" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-routine-drug-product.html">Routine Drug Product</a></p></div><p><b>identifier</b>: Example2BeadDrug</p><p><b>combinedPharmaceuticalDoseForm</b>: CAPSULE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C25158)</span></p><p><b>route</b>: ORAL <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C38288)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg</p><p><b>type</b>: Non-Proprietary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-product-name-types.html">Product Name Types Code Types</a>#NON)</span></p><blockquote><p><b>part</b></p><p><b>part</b>: OXAZEPAM</p><p><b>type</b>: scientific name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html">EntityNamePartQualifierR2</a>#SCI)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 30mg</p><p><b>type</b>: strength name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html">EntityNamePartQualifierR2</a>#STR)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: PROPRANOLOL HYDROCHLORIDE</p><p><b>type</b>: scientific name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html">EntityNamePartQualifierR2</a>#SCI)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 60mg</p><p><b>type</b>: strength name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-EntityNamePartQualifierR2.html">EntityNamePartQualifierR2</a>#STR)</span></p></blockquote></blockquote></div>
</text>
<identifier>
<value value="Example2BeadDrug"/>
</identifier>
<combinedPharmaceuticalDoseForm>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C25158"/>
<display value="CAPSULE"/>
</coding>
</combinedPharmaceuticalDoseForm>
<route>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C38288"/>
<display value="ORAL"/>
</coding>
</route>
<name>
<productName value="OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-product-name-types"/>
<code value="NON"/>
<display value="Non-Proprietary"/>
</coding>
<text value="Non-Proprietary"/>
</type>
<part>
<part value="OXAZEPAM"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="SCI"/>
</coding>
</type>
</part>
<part>
<part value="30mg"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="STR"/>
</coding>
</type>
</part>
<part>
<part value="PROPRANOLOL HYDROCHLORIDE"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="SCI"/>
</coding>
</type>
</part>
<part>
<part value="60mg"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="STR"/>
</coding>
</type>
</part>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"/>
<resource>
<Organization>
<id value="4f3e9af1-306b-4fad-bf04-7881400b266a"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><p><b>Generated Narrative: Organization</b><a name="4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><a name="hc4f3e9af1-306b-4fad-bf04-7881400b266a"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Organization "4f3e9af1-306b-4fad-bf04-7881400b266a" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-cmc-sponsor-organization.html">Sponsor Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>
</text>
<identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134003"/>
<display value="DUNS"/>
</coding>
</type>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="143265222"/>
</identifier>
<name value="Wunderwerke"/>
<contact>
<address>
<text
value="Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478"/>
<line value="123 Scenic Road"/>
<city value="Bridgeport"/>
<state value="CT"/>
<postalCode value="65478"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
</Bundle>
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-08
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